Embodiments described herein relate generally to systems, devices and methods for serializing and subsequent aggregation of serialized goods such as, for example, pharmaceutical products to allow tracking and tracing of goods with high fidelity.
Product counterfeiting and diversion is typically a major concern for manufacturers. In particular, product counterfeiting in the pharmaceutical industry can result in substantially less revenue for pharmaceutical companies and can jeopardize the health and confidence of patients taking medication. According to the World Health Organization (WHO), up to 15 percent of all medical products in the world are estimated to be counterfeits and the problem is rising. In order to combat counterfeit products, new standards for tracking and tracing medical products need to be developed and implemented globally.
A known method for preventing counterfeiting and diversion, misuse and abuse of pharmaceutical and medical device products is serialization. Serialization is the process of creating and applying unique traceable serial numbers, for example, bar codes to goods such as medical products, at each packaging stage. For example, the unique traceable serial numbers can be applied to bottles or boxes, and aggregates of products such as, for example, bundles, cases, and/or pallets. This information can be managed, stored digitally/electronically and exchanged with key stake holders in the product packaging line and distribution supply chain to ensure that only authentic products are delivered to consumers.
Recent and pending government regulatory requirements are requesting implementation of global drug traceability systems to fight counterfeiting and diversion. This will protect public health against illicit product introduction within the supply chain. Many pharmaceutical and biomedical manufacturers are, however, discovering that their legacy packaging systems are not configured to support the new serialization and track and trace requirements. Most existing packaging lines have manual packaging operations and product manufacturers are reluctant to upgrade their packaging capabilities to be compatible with serialization and tracking systems due to concerns about significant cost impact of such modifications and development of customized packaging lines for one specific product and package size.
Therefore, there is a need for new systems, devices and methods for serializing and aggregating serialized goods products which can relatively easily integrate into existing manual packaging lines of medical product manufacturers. There is also a need for new portable systems that can be moved from one packaging suite or area to another.